Kornimate/medical-research-clean huggingface dataset:
clinical application of intrapartum ultrasound

Conditions: Abnormal Labor; Complication of Delivery

Summary: intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research.

intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research. all pregnant women intending to have a vaginal delivery were enrolled in the study. after admission, women were randomly assigned to either intrapartum ultrasound (ipus) or vaginal examination (ve). in ipus group, the patient was evaluated by ultrasound, including fetal orientation, pelvic and cervical conditions. ipus and ve were performed every 2 to 4 hours during the first stage of labor and at least hourly during the second stage. the progress of labor, the occurrence of complications and the prediction of the success rate of vaginal delivery were observed. finally, the investigators compared whether there were any differences in labor and vaginal delivery complications between the two groups.

Eligibility criteria:
inclusion criteria: * all pregnant women in the delivery room for vaginal trial labor exclusion criteria: * those who reject ultrasound
safety study of a vaccine against meningitis in infants ( 2,4 & 6 months age) after a birth dose of hepatitis b.

Conditions: Diphtheria; Hepatitis B; Whole Cell Pertussis; Haemophilus Influenzae Type b; Tetanus

Summary: the purpose of this study is to compare the reactogenicity \& safety of tritanrix™-hepb/hib-menac vaccine to the international standard of care, tritanrix™-hepb/hiberix™.

randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis b vaccine given at birth: - one of the 3 lots of gsk biologicals' hib-menac mixed with gsk biologicals' tritanrix™-hepb (3 different groups) - gsk biologicals' tritanrix™-hepb/hiberix™

Eligibility criteria:
inclusion criteria at study entry: * healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. exclusion criteria at study entry: * any confirmed immunodeficient condition, based on medical history \& physical examination. * a family history of congenital or hereditary immunodeficiency. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * acute disease at the time of enrolment.
expressive writing for individuals with parkinson's disease and their caregivers

Conditions: Parkinson's Disease; Coping Skills

Summary: this randomized, controlled trial (rct) evaluates the benefits of expressive compared to neutral writing in individuals with parkinson's disease and their support persons. participants will be randomly assigned to complete three, 20 minute sessions of expressive or neutral writing. participants will complete evaluation of outcomes at baseline, immediate post, 4 month and 10 month follow ups to establish if benefits remain over time. impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. expressive writing is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the neutral writing condition. results from this study will determine whether brief writing exercises are easily used by and beneficial for individuals with parkinson's disease and their support persons. if positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with parkinson's disease and their support persons.

the expressive writing condition asks participants to write about the most stressful or traumatic experience of their entire lives over three, 20 minute private writing sessions. the neutral control writing conditions asks participants to write about how they spent their time the day before.

Eligibility criteria:
inclusion criteria: clinical diagnosis of parkinson's disease caregiver of an individual with parkinson's disease exclusion criteria: clinical diagnosis of dementia clinical diagnosis of other parkinson's disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing

Keywords: parkinson's disease caregivers expressive writing complementary medicine cortisol
research study in patients with advanced ovarian epithelial cancer

Conditions: Ovarian Serous Cystadenocarcinoma; Ovarian Serous Surface Papillary Adenocarcinoma; Stage IIIA Ovarian Cancer; Stage IIIB Ovarian Cancer; Stage IIIC Ovarian Cancer; Stage IV Ovarian Cancer

Summary: this research trial studies tissue samples from patients with ovarian cancer in the laboratory. analyzing tissue samples from patients in the laboratory may help doctors learn more about cancer.

objectives: i. utilize array comparative genomic hybridization and taqman analyses, a quantitative genomic polymerase chain reaction, to validate the observation that a gain in chromosome 8q is predictive of shorter progression-free survival in patients with primary grade 2 or grade 3 advanced serous papillary ovarian cancer. ii. utilize these analyses to determine whether a gain in chromosome 8q is predictive of worse overall survival in these patients. iii. utilize these analyses to determine whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome in these patients and the association between these changes and clinical characteristics. iv. utilize these analyses to identify up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival) in these patients. outline: genomic dna is isolated from optimal cutting temperature (oct)-embedded tissue and analyzed using comparative genomic hybridization. the chromosomal changes identified by this method are compared to those identified using the taqman method, a quantitative genomic polymerase chain reaction analysis. chromosome 8q is of specific interest. other chromosomal changes may be detected in chromosomes 3q, 7q, 16q, and/or 17pter-q21.

Eligibility criteria:
inclusion criteria: * stage iii or iv, high-grade (grade 2 or 3) ovarian cancers * no borderline or low-grade (grade 1) tumors * tissue from predominately serous ovarian cancer only * no clear cell, endometrioid, mucinous, transitional cell, or mixed without predominant serous component * tissue obtained during prior optimal or suboptimal cytoreductive surgery * must be enrolled on gog-0136 and a gog front-line paclitaxel/platinum chemotherapy trial * frozen tissue and hematoxylin-eosin stained section from the ovary obtained at initial surgery * performance status - gog 0-2
a study comparing the influence of a mindfulness-based stress reduction program vs. routine management on psychological variables and biological markers related to immuno-inflammation associated with psychological stress in caregivers of patients with severe psychiatric disorders

Conditions: Psychiatry; Caregivers; Mindfulness

Summary: the objective of this project is to study the influence of mindfulness meditation on psychological health (stress level, affects, emotions) and physical health parameters (rate of inflammatory markers in the blood, activity of white blood cells involved in immuno-inflammation) in caregivers of people with psychiatric disorders. this study will provide the objective scientific data required for the development of mindfulness meditation programs for psychiatric caregivers. 80 participants will be randomly assigned to one of the following two groups: * 40 participants in the "mindfulness" group who will attend mindfulness meditation sessions in addition to their standard follow-up * 40 participants in the "control" group who will have a standard follow-up the duration of participation is 12 months and includes 3 visits and 8 mindfulness-based meditation sessions for the "mindfulness" group.


Eligibility criteria:
inclusion criteria: * patient who has given oral consent * adult patient * a caregiver of a person with a severe psychiatric disorder (schizophrenia, recurrent depression, bipolar disorder, obsessive-compulsive disorder) exclusion criteria: * protected adult * patient not affiliated to the national health insurance system * pregnant, parturient or breastfeeding woman * person suffering from a severe psychiatric disorder indicating a state of decompensated stress (with risk of associated biological inflammatory disturbances) * person suffering from an inflammatory disease (autoimmune, infectious, neoplastic, cardio-vascular pathologies
multi-center ocular biological parameters study

Conditions: Cataract

Summary: this study is a multi-center study, which collects data from multiple regions to obtain the general biological characteristics of the chinese population. the formula for calculating the artificial lens power based on foreign populations is effectively modified based on the chinese population.

①relevant domestic studies on the biological characteristics of the eye are mainly limited to a certain city and region. most of the studies that represent the biological characteristics of the general population in china and the differences in biological parameters at home and abroad are in the research process, or semi-finished products. ②the investigators found in clinical observation that the eyeball biological data of the chinese population may not be consistent with the foreign population. ③ this study is the first study of human eye biological parameters based on different regions of large-scale populations in china, which is of great significance for understanding the human eye structure in different regions of china.

Eligibility criteria:
inclusion criteria: * patients aged over 50 years exclusion criteria: * history of refractive surgery, * corneal diseases * ocular inflammation * trauma

Keywords: corneal astigmatism axial length (al), anterior chamber depth (acd) partial coherence interferometry
a study to assess the therapeutic effect and safety of adjunctive akst4290 in subjects with bullous pemphigoid

Conditions: Pemphigoid, Bullous

Summary: this study will evaluate the therapeutic effect and safety of adjunctive akst4290 in subjects with bullous pemphigoid (bp).

this is a randomized, double-blind, placebo-controlled study to assess the therapeutic effect and safety of adjunctive akst4290 in subjects with bullous pemphigoid (bp). subjects will receive topical mometasone furoate cream (mfc) therapy concurrently with study agent (placebo or akst4290) in an inpatient setting until disease control is reached (duration of inpatient stay is dependent upon individual disease course, but is estimated between 1-3 weeks). subjects will receive rescue therapy at any time if their clinical condition worsens or if their clinical condition fails to improve by the completion of week 1 on study treatment, as assessed by the investigator. rescue therapy will consist of whole-body clobetasol propionate cream (cpc) (15-50g) and/or oral prednisone (0.5 mg/kg per day), as determined by the investigator. subjects who receive rescue therapy will remain in the study until disease control, unless they are withdrawn or withdraw from participation.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mild to moderate bp at screening. * treatment naïve or initiation of whole-body high potency topical steroid treatment ≤ 7 days of screening (lesion-only treatment for any amount of time with any topical steroids prior to screening is allowed without restriction). * provide a signed and dated informed consent form in accordance with local regulations and/or irb/iec guidelines. exclusion criteria: * severe bp. * initiation of gliptins and other treatments (e.g., etanercept, sulfasalazine, furosemide, penicillin) that can trigger bp if this treatment was started within 4 weeks prior to screening and is considered possibly related to the onset of bp. * any concomitant medications in the last 3 months prior to screening and assessed by the investigator as possibly related to the development of bp. * planned use of intravenous immunoglobulin or other concomitant treatments for bp (i.e., doxycycline, dapsone) during the study period. * use of systemic immunosuppressants (i.e., mycophenolate, azathioprine, methotrexate) within 4 weeks prior to screening. * treatment with rituximab within 1 year prior to screening. * subjects taking warfarin. * use of systemic steroids (\>10 mg prednisone or equivalent/day) within 14 days of first dose of study agent or known diseases (other than bp) that could require the use of systemic steroids within the study period. * clinically relevant abnormal laboratory value at screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the screening phase). * participation in studies of investigational drugs must have been discontinued within 30 days or 5 half lives of the drug (whichever was longer) prior to screening.

Keywords: autoimmune disease skin disease vesiculobullous
study of the effect of renal impairment on the pharmacokinetics of vepoloxamer

Conditions: Pharmacokinetics of Vepoloxamer; Healthy Volunteers; Renal Impaired

Summary: this is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function.


Eligibility criteria:
key inclusion criteria: * subject must weigh ≤ 125 kg and have a body mass index between 20 and 40 kg/m2 * subject must be willing to be confined in the clinical research unit for the duration of the study, up to 5 days * if female, subject must not be pregnant or lactating, have a negative pregnancy test, and agrees to sexual abstinence, or use of an appropriate birth control method from screening through 30 days after study drug administration * if male, subject agrees to sexual abstinence, is surgically sterile, or is using an appropriate birth control method from screening through 30 days after study drug administration * considered by the investigator to be healthy or clinically stable with respect to underlying renal impairment based on medical evaluation including vital signs, ecg and laboratory test results * non-smoker, or smokes fewer than 10 cigarettes/day key exclusion criteria * uncontrolled medical condition (treated or untreated) considered to be clinically significant by the investigator * experienced an illness considered by the investigator to be clinically significant within 2 weeks of study drug administration * treatment with another investigational drug or device study within 30 days or 5 half-lives (whichever is longer) prior to screening * positive test for drugs of abuse and/or positive alcohol test at screening or day -1 * donated or lost a significant volume of blood or plasma within 90 days prior to study drug administration
moisturizer mediated prevention of symptoms of atopic dermatitis in early childhood

Conditions: Atopic Dermatitis; Infant, Newborn

Summary: in this study, it will be investigated if symptoms of atopic dermatitis of children with high familial risk will be delayed beyond the 6th or even 12th month of life by applying the sanacutan basiscreme.

enrolled healthy newborns with high risk for atopic dermatitis will be 1:1 randomised into treatment and control group. the treatment group receives the sanacutan basiscreme for twice daily skin application until the age of 6 months (main phase; half of them until the age of 12 months (main + follow-up phase)), whereas the control group should avoid skin care products. guardians of both groups are requested to document all applied skin care products in a diary. in regular visits at the study sites, a blinded physician investigates the skin of the children. in case of an atopic dermatitis (= atopic dermatitis has to be diagnosed in at least two visits with an interval of at least four weeks), the severity will be examined (scorad) and the treatment with sanacutan basiscreme will be terminated. all children will be followed up until the age of 6 months (end of main phase). this is the time when a blood test will be conducted to determine sensitization against food and inhalant allergens and total ige. if children do not develop an atopic dermatitis in the main phase, the study continues until they receive the diagnosis (up to a maximum of 12 months, end of follow-up phase).

Eligibility criteria:
inclusion criteria: * healthy newborns (male or female) * age \< 3 weeks (≤ 21st day of life) * high familial risk of atopic dermatitis in the form of at least one first-degree relative (parent or sibling) with a medically diagnosed atopic dermatitis in the medical history * written consent of all guardians exclusion criteria: * acute or chronic diseases * acute fever (\> 38.5 °c) * severe congenital malformations * hydrops fetalis * immunodeficiency (any kind) * severe genetic skin diseases or skin conditions that make the use of skin creams unsuitable * corticoid or calcineurin inhibitor use or ciclosporin intake * preterm birth (\< 37 weeks) * known hypersensitivity to one of the ingredients of the sanacutan basiscreme * restricted legal capacity of the guardians * inability of the guardians to understand the study instructions * obvious unreliability or lack of cooperation of the guardians * known alcohol, medicine or drug dependency of the guardians * dependence of the child or guardians on the sponsor or the investigator * previous participation in another clinical trial (since birth) * previous participation in this study

Keywords: skin care prevention risk factor interventional study multicentric
a study of adr-001 in patients with liver cirrhosis

Conditions: Decompensated Liver Cirrhosis

Summary: this is a first-in-human phase1/2 study of adr-001, adipose-derived mesenchymal stem cells (ad-mscs). the safety and preliminary efficacy are evaluated in phase 1 in patients with liver cirrhosis caused by hepatitis c or nonalcoholic steatohepatitis and a recommended phase 2 dose is determined by the evaluation. the exploratory efficacy and safety are investigated against the same target population in phase 2.

patients with decompensated liver cirrhosis (child-pugh score; grade b) caused by hepatitis c or nonalcoholic steatohepatitis are enrolled to the study. in phase 1, one of 3 doses of ad-mscs is administered by 1 hour single intravenous infusion. patients are hospitalized for 1 week and a recommended dose for phase 2 is determined by the evaluation of the safety and efficacy. in phase 2, patients with the same disease criteria are enrolled and dosed to investigate the exploratory efficacy and safety. the safety and efficacy are evaluated until 24 weeks after dosing both in phase 1 and phase 2.

Eligibility criteria:
inclusion criteria: * men and women ≥ 20 years of age * chronic hepatitis c or nonalcoholic steatohepatitis(nash) * child-pugh grade b liver cirrhosis * ecog performance status ≤ 2 exclusion criteria: * liver cirrhosis patients other than hepatitis c or nash * malignant neoplasm (except hepatocellular carcinoma patients without recurrence more than 2 years) * history of venous thrombosis or pulmonary embolism * serum creatinine ≥ 2 mg/dl or t-bil ≥ 5.0 mg/dl * infection with hepatitis b, hiv, atlv-1 or parvovirus b19 * patients experienced transplantation or cell therapy * pregnancy or positive on pregnancy test * complications of significant heart disease, kidney disorder, or respiratory disease * drug or alcohol abuse
azelaic acid iontophoresis versus topical azelaic acid cream in the treatment of melasma

Conditions: Melasma

Summary: the purpose of this prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of azelaic acid iontophoresis (aai) versus topical treatment with azelaic acid cream in female patients with melasma.

patients will be randomized and allocated in concealed manner to one of the two treatment arms: aai or topical azelaic acid cream. azelaic acid iontophoresis treatment schedule: patients randomized to the aai group will receive iontophoresis with 15% azelaic acid twice weekly over a period of 12 weeks. azelaic acid topical treatment schedule: patients randomized to the topical treatment group will receive topical treatment with 20% azelaic acid cream twice daily over a period of 12 weeks. besides emollients no additional specific treatments will be allowed during the study. the use of broad spectrum (uva+uvb) sunscreen is recommended over the entire study period (9 month). follow-up period: after completion of the active study period (3 month in both treatment groups), maintenance and efficacy of both treatment schedules will be followed up quarterly over 6 month

Eligibility criteria:
inclusion criteria: * woman * masi - score over 6 * age: over 18 years * skin type: iii, iv, v exclusion criteria: * skin type: i, ii, vi * pregnant or lactating women * local therapy of intent-to-treat area within the last 6 month * patient with a pacemaker or metal implant * epileptic * mental incompetence to understand the protocol * known allergic reactions to one of used substances * serious encroachment on physical condition

Keywords: azelaic acid iontophoresis